Clinician’s Manual - St. Jude Medical/media/manuals/product-manual-pdfs/9/8/... · Precautions ... Configuring Electrode Polarities ... therapy and be experienced diagnosing and

Rapid Programmer™ System, Version 3.7Model 3834

Clinician’s Manual

CAUTION: The Rapid Programmer™ system is part of a regulated

medical device system and any changes to the system may be

performed only with express written authorization from St. Jude

Medical. Changes to the system include the installation of any

software, addition of hardware that is not approved by St. Jude

Medical, or modifications to the operating system of the personal

digital assistant (PDA). The result of these actions may cause the

PDA to malfunction or become inoperable.

CAUTION: Federal (USA) law restricts this device to sale by or on

the order of a physician.

Information in this document is subject to change without notice and does not represent a commitment on the part of St. Jude Medical. The Rapid Programmer system software, excluding any user-input data, is furnished under a license agreement or nondisclosure agreement and may be used or copied only in accordance with the terms and conditions of the applicable agreement.

Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

Pat. http://patents.sjm.com

© 2016 St. Jude Medical, Inc. All rights reserved.

Rapid Programmer System Clinician’s Manual i

Contents

Prescription and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . 1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Prescription Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Device Compatibility Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . 4

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Contents of Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Parts of the Rapid Programmer System . . . . . . . . . . . . . . . . . . . . 7

Setting Up the Rapid Programmer System . . . . . . . . . . . . . . . . . . . . 9Inserting the System Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Charging the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Turning the System On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . 11Connecting a Patient Programmer . . . . . . . . . . . . . . . . . . . . . . . . 12Connecting an MTS System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Inserting a Database Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Removing a Database Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Replacing the System Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Navigating the Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . 18Adjusting Backlight Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Adjusting Screen Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Checking the Programmer Battery Status . . . . . . . . . . . . . . . . . . . 22Adjusting the Automatic Shutoff Settings . . . . . . . . . . . . . . . . . . . 23Calibrating the Touch Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Adjusting the Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Starting the Demo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Clinician’s Manual

ii Rapid Programmer System Clinician’s Manual

Intraoperative and Postoperative Programming . . . . . . . . . . . . . . . . . 27Buttons and Icons on the Programming Screens . . . . . . . . . . . . . . 27Starting an Intraoperative Testing Session . . . . . . . . . . . . . . . . . . 29Starting a New Programming Session or Resuming the

Previous Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Selecting the Lead Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 34Resetting the Hours Used for the MTS System . . . . . . . . . . . . . . . 34Adding a New Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Copying a Selected Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Editing a Selected Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Deleting a Selected Program, Stim Set, or Burst Pulse . . . . . . . . . 36Switching Between Tonic Mode and

BurstDR™ Stimulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 37Configuring Electrode Polarities . . . . . . . . . . . . . . . . . . . . . . . . . . 38Adjusting Pulse Width. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Adjusting Frequency for Tonic Programs . . . . . . . . . . . . . . . . . . . . 39Adjusting Frequency for BurstDR™ Stimulation Programs . . . . . . . 39Adjusting Amplitude and Step Size . . . . . . . . . . . . . . . . . . . . . . . 40Setting Perception and Comfort Amplitudes for Tonic Programs . . . 40Setting the Target Amplitude for

BurstDR™ Stimulation Programs . . . . . . . . . . . . . . . . . . . . . . . 41Adding a Stim Set or a Burst Pulse to a Program . . . . . . . . . . . . . 41Using the MultiSteering Programming Feature . . . . . . . . . . . . . . . 42Creating a Stimulation Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Using the Dynamic MultiStim Programming Feature . . . . . . . . . . . 45Viewing the Test Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Measuring Impedance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Modifying IPG Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Saving a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Using the Active Balancing Programming Feature . . . . . . . . . . . . . 52Downloading Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Overriding the Usage Range for Amplitude . . . . . . . . . . . . . . . . . . 55

Managing Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Buttons and Icons on the Patient Database Screens . . . . . . . . . . . 57Accessing the Patient Database . . . . . . . . . . . . . . . . . . . . . . . . . . 58Changing the Password for the Patient Database . . . . . . . . . . . . . . 60Adding a Patient to the Database. . . . . . . . . . . . . . . . . . . . . . . . . 61Editing a Patient’s Information . . . . . . . . . . . . . . . . . . . . . . . . . . 62Deleting a Patient From the Database . . . . . . . . . . . . . . . . . . . . . 63Combining Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Merging and Copying Patient Databases . . . . . . . . . . . . . . . . . . . . 65Exporting Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Restoring a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Rapid Programmer System Clinician’s Manual iii

Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Types of Printable Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Printing a Neurostimulation Record . . . . . . . . . . . . . . . . . . . . . . . 69Printing the Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Printing a Lead Diagnostics Report . . . . . . . . . . . . . . . . . . . . . . . 71

Cleaning and Maintaining the Rapid Programmer System . . . . . . . . . 72Handling the Programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Cleaning the Programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Storing and Transporting the Programmer . . . . . . . . . . . . . . . . . . . 73

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Troubleshooting Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Performing a Soft Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Reinstalling the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Copying Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Returning the Rapid Programmer System for Service . . . . . . . . . . . 82

Service and Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . 83Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Appendix A: Printable Reports of the Rapid Programmer System . . . . 85Neurostimulation Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Lead Diagnostics Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Appendix B: Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Appendix C: Regulatory Statements. . . . . . . . . . . . . . . . . . . . . . . . . 88Statement of FCC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Declaration of Conformity (Industry Canada) Notice to

Users of Radio and Television. . . . . . . . . . . . . . . . . . . . . . . . . . 88Disposal Guidelines for Battery-Powered Devices . . . . . . . . . . . . . . 89

Appendix D: Symbols and Definitions . . . . . . . . . . . . . . . . . . . . . . . 90

Appendix E: Electromagnetic Compatibility Guidelines . . . . . . . . . . . 92

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Rapid Programmer System Clinician’s Manual 1

Prescription and Safety Information

Read this section for important prescription and safety information.

NOTE: The information contained in this manual is provided solely for operating the Rapid

Programmer™ system and must not be considered all-inclusive with respect to a St. Jude

Medical™ neurostimulation system or other system components. Before using the Rapid

Programmer system to program a patient, you should thoroughly read this manual and

become familiar with using the components of the neurostimulation systems that the Rapid

Programmer system supports.

Intended Use

The Rapid Programmer™ system is intended to help clinicians determine

the best performance of a neurostimulation system by leading the patient

through a series of parameter combinations for the neurostimulation system

and recording the stimulation effects. The system is intended to be used for

programming while it is disconnected from an external power source.

Prescription Information

Refer to the clinician’s manual for the appropriate device to get specifi c

instructions and other important information, including indications for use,

contraindications, warnings, precautions, and adverse effects related to

those components.

Warnings

The following warnings apply to the programming system:

Explosive or fl ammable gases. Do not use programming devices in an

environment where explosive or fl ammable gas vapors are present. The

operation of programming devices could cause these vapors to ignite

resulting in severe burns, other injuries, or death.

Battery warning. This device contains a lithium ion rechargeable battery . To

reduce the risk of fi re or burns, do not disassemble, crush, puncture, short

external contacts on, or dispose of the battery in fi re or water. Do not insert

metal objects into the charging or communications ports of the device.

This can short-circuit the battery and result in danger. Replace the battery

with only an authorized spare. A risk of explosion is possible if the battery

is replaced by an incorrect battery type. Keep battery packs away from

children.

2 Rapid Programmer System Clinician’s Manual

Case damage. If the programmer case is pierced or ruptured, injury could

result from exposure to the battery chemicals or sharp edges. Inspect

programmer integrity before use. Do not use if the device shows signs of

damage. Return to St. Jude Medical for evaluation.

Shock hazards. To prevent electrical shock, (1) Use this device to program a

patient programmer or a trial system only when it is operating under battery

power and is not connected to a power outlet or to any external accessories;

(2) do not expose the system to rain or moisture; and (3) do not open the

outer case of the system or the system’s power supply. No part of this

product is serviceable by the user. Refer servicing to qualifi ed personnel

only.

Device components. The use of components not approved for use by

St. Jude Medical may result in damage to the system and increased risk to

the patient.

Precautions

The following precautions apply to the programming system:

Nonsterile device. The medical device system comprised of the programmer

and other St. Jude Medical devices as specifi ed in this document must

be used in accordance with IEC 60601-1-1 for patient programming .

This device is a nonsterile device and must be kept out of the sterile fi eld

(patient environment).

Clinician training. Clinicians should be familiar with neurostimulation

therapy and be experienced diagnosing and treating the indication for which

the neurostimulation system components are being used.

Device inspection. Before operating the system each time, inspect the

device and all its components for mechanical and electrical integrity. Avoid

using the system if the device or its components are damaged. Return

damaged components to St. Jude Medical for evaluation.

Position the power cord carefully. Position the power adapter so that it will

not be walked on, tripped over, or pinched by items placed upon or against

it. Pay particular attention to the plug, electrical outlet, and the point where

the power adapter exits the product.


Unplug the power cord properly. When unplugging the power adapter from

an electrical outlet, do not pull on cords and cables. Grasp and pull from

the plug.

Avoid hot areas. The product should be placed away from heat sources such

as radiators, heat registers, stoves, and other products that produce heat.

If the product shows noticeable signs of damage due to overheating, do not

use it. Return damaged components to St. Jude Medical for evaluation.

Avoid blocking the vents. Slots and other openings are provided for

ventilation. To prevent overheating, do not obstruct vents. Using the device

on a soft surface, such as a pillow, blanket, rug, or thick clothing may block

airfl ow.

Battery inspection. Periodically before using the programmer, check the

programmer battery for bulging due to aging or other damage. Avoid using

the programmer if the battery is deformed.

Device modifi cation. To prevent damage to the system, do not modify the

device in any way.

Patient contact. Avoid making contact with the patient when using the

device.

Electromagnetic interference (EMI). Certain commercial electrical

equipment (e.g., some computer monitors, arc welders, induction furnaces,

and resistance welders), communication equipment (e.g., microwave

transmitters, linear power amplifi ers, and high-power amateur transmitters),

and high-voltage power lines may generate suffi cient EMI to interfere with

the operation of a neurostimulation system if they are approached too

closely.

Wireless use restrictions. In some environments, the use of wireless

functions (e.g., Bluetooth® wireless technology) may be restricted. Such

restrictions may apply aboard airplanes, in hospitals, near explosives, or in

hazardous locations. If you are unsure of the policy that applies to the use

of this device, please ask for authorization to use it before turning it on.


Device Compatibility Guidelines

Only the following St. Jude Medical™ components may be used with the

Rapid Programmer™ system:

Patient Programmer, Models 3850, 3851, 3852, 3853, 3855, and

3856

MTS™ system

Bluetooth® printer, Model 3823

Rapid Programmer system accessories (see the “Ordering Information”

section)

No other components may be connected to the Rapid Programmer system.

Use only St. Jude Medical-approved accessories with the Rapid Programmer

system. Use only the power adapters and power supply that are supplied

with the system or from St. Jude Medical as a replacement.


Product Description

The Rapid Programmer™ system interfaces with St. Jude Medical™

neurostimulation systems and is intended to be used to noninvasively

control device parameters. The Rapid Programmer system software is

installed only on a St. Jude Medical-approved PDA. Users interface with the

software and enter data using a stylus.

Contents of Package

The Rapid Programmer™ system (Model 3834) comes with the following

items.

Table 1: Package contents of the Rapid Programmer system

Item Description

Rapid Programmer

(Model 3834)

Interfaces with St. Jude Medical

neurostimulation systems and

allows you to noninvasively

control device parameters

Power adapter

(included with

Model 3834)

Allows you to use a wall outlet

as a power source to charge the

Rapid Programmer system

MTS communication

cable (Model 1273)

Connects an MTS system to the

CF card cable

IrDA communication

cable (Model 1280)

Connects a patient programmer

to the CF card cable

AAA batteries

(included with

Model 1280)

Provide power for the IrDA

communication cable


Item Description

Compact fl ash to DB9

cable (CF card cable,

Model 1291)

Connects the Rapid

Programmer system to the MTS

communication cable or IrDA

communication cable

Stylus for RP Model

3834 (Model 1626)

Allows you to operate the touch

screen of the Rapid Programmer

system

Extended battery for

RP Model 3834

(Model 1629)

Provides power for the Rapid

Programmer system

Rapid Programmer

database card

(Model 3805)

Stores patient data and Rapid

Programmer system information


Parts of the Rapid Programmer System

The following images provide information about the parts of the Rapid

Programmer™ system:

1

3

2

4

5 6 7 8 9

Figure 1: Front of the Rapid Programmer system

Legend:

1. Power button

2. Light sensor

3. Power and Bluetooth® LEDs

4. Touch screen

5. Inactive button

6. Inactive button

7. Inactive button

8. Inactive button

9. Inactive button

1

2

Figure 2: Back of the Rapid Programmer system

Legend:

1. Back speaker

2. Battery compartment cover


1

3

2

4 5 6

Figure 3: Top and bottom of the Rapid

Programmer system

Legend:

1. CF card slot

2. Database card slot

3. Not used

4. AC 24-pin adapter port

5. Charger port

6. Not used

1

3

2

Figure 4: Sides of the Rapid Programmer system

Legend:

1. Inactive button

2. Stylus

3. Soft reset button


Setting Up the Rapid Programmer System

The following sections provide instructions for setting up the Rapid

Programmer™ system.

Inserting the System Battery

When you receive your system, the programmer’s rechargeable lithium ion

battery is removed and needs to be inserted. To insert the programmer

battery , follow these steps:

1. Using your thumbnail, press in at the notch on the side of the battery

compartment cover.

2. Pull up to remove the cover from the back of the programmer.

1

2

Figure 5: Sequence for removing the battery compartment cover


3. Hold the end of the battery release ribbon outside the battery

compartment, and insert the new battery by aligning the pins on the

bottom of the battery with the housing in the battery compartment.

Ensure that the ribbon is exposed after pressing the battery into place.

Figure 6: Inserting the battery

4. Insert the left side of the battery compartment cover into the notches

in the left side of the battery compartment, and press the cover closed.

Charging the System

Before you use the system for the fi rst time, you need to fully charge the

system. You can charge the system using either the power adapter or the car

charger (sold separately).

NOTE: A solid amber light on the front of the programmer indicates that the battery is

charging. When the battery is fully charged, the light turns solid green.

WARNING: Do not program a patient while the system is being

charged.


Using the Power Adapter

To charge the system using the power adapter, follow these steps:

1. Insert the appropriate plug accessory into the slot on the power adapter.

2. Plug the power adapter into an electrical outlet.

3. Insert the other end of the power adapter into the 24-pin power

adapter port on the bottom of the programmer.

1

3

2

Figure 7: Sequence for connecting the power adapter for charging

Using the Car Charger

To charge the system using the car charger, follow these steps:

1. Assemble the car charger by connecting the cable to the socket plug.

2. Plug the car charger into the automobile’s cigarette lighter socket.

3. Insert the other end of the car charger into the corresponding charger

port on the bottom of the programmer.

Turning the System On and Off

To turn the system on or off, press the power button on the upper right

corner on the front of the programmer.


Connecting a Patient Programmer

To connect a patient programmer to the Rapid Programmer™ system, follow

these steps:

NOTE: To keep the CF card connected to its cable, handle all cables with care while inserting

and connecting them.

CAUTION: To avoid damaging the IrDA communication cable, do

not remove the ribbon from the battery compartment end of the

IrDA communication cable.

1. If necessary, remove the protective plastic card from the CF card slot

on the top of the Rapid Programmer system.

2. Insert the CF card cable into the Rapid Programmer system (see the

following figure, left). Ensure the proper orientation of the card; the

“FRONT” label on the CF card should face the front the programmer.

3. If needed, insert three AAA batteries (included) into the battery

compartment end of the IrDA cable.

4. Connect the 9-pin connection end of IrDA cable to the CF card cable,

and then connect the battery compartment end of the IrDA cable to the

patient programmer (see the following figure, right).

Figure 8: Connecting the CF card cable Figure 9: Connecting the IrDA cable


Connecting an MTS System

To connect an MTS™ system to the Rapid Programmer™ system, follow

these steps:

NOTE: To keep the CF card connected to its cable, handle all cables with care while inserting

and connecting them.

1. If necessary, remove the protective plastic card from the CF card slot

on the top of the Rapid Programmer system.

2. Insert the CF card cable into the Rapid Programmer system (see

the previous figure, left). Ensure the proper orientation of the card;

the “FRONT” label on the CF card should face the front of the

programmer.

3. Open the communication port door on the MTS system.

NOTE: You may need to unlock the communication port door before connecting the

communication cable to the MTS system. To unlock the communication port door, insert

the stylus or a similar object into the release port of the MTS system, and slide the door

until the communication port is exposed. After you are fi nished using the MTS system,

close and lock the communication port door.

4. Insert the MTS communication cable plug into the MTS communication

port.

3

2

1

Figure 10: Plugging the MTS communication

cable into the communication port

Legend:

1. Communication port

2. Communication port door

3. Release port


5. Connect the 9-pin connection end of the MTS communication cable to

the CF card cable.

Figure 11: Connecting the MTS communication cable to the CF card cable


Inserting a Database Card

To insert a database card into the programmer, follow these steps:

1. If necessary, remove the protective plastic card from the database

card slot.

2. With the database card label facing toward the front of the programmer

and the gold pins facing toward the back, insert the card into the

database card slot and press until the card is seated flush with the top

edge of the programmer.

CAUTION: To avoid damaging the system, insert the database card

with the label facing toward the front of the programmer.

Figure 12: Inserting the database card


Removing a Database Card

To remove a database card from the programmer, follow these steps:

1. Ensure that the system is turned off or that you are on the Main Menu

screen.

NOTE: The system database can be corrupted if a user removes the database card while

the programmer is writing to the card. If the database gets corrupted, all data will be lost.

2. Push down slightly on the database card and release to unseat it.

3. When the card pops up, pull it from the database card slot.

Figure 13: Removing the database card


Replacing the System Battery

If the system battery reaches the end of its life, you will need to replace

the battery with a St. Jude Medical-approved spare. To replace the system

battery , follow these steps:

1. Ensure that the system is turned off.

2. Using your thumbnail, press in at the notch on the side of the battery

compartment cover and then pull up to remove the cover from the back

of the programmer.

3. To release the battery , gently pull the ribbon straight out from the

programmer.

Figure 14: Releasing the battery

4. Remove the battery .

5. Hold the end of the battery release ribbon outside the battery

compartment, and insert the new battery by aligning the pins on the

bottom of the battery with the housing in the battery compartment.

Ensure that the ribbon is exposed after pressing the battery into place.

6. Insert the left side of the battery compartment cover into the notches

in the left side of the battery compartment, and press the cover closed.


Getting Started

This section contains information about icons and buttons and

provides instructions for performing basic functions, such as adjusting

programmer settings.

Navigating the Main Menu Screen

When you turn on the Rapid Programmer™ system, the Main Menu screen

appears. From the Main Menu screen, you can access the different user

screens and menus. The following table provides defi nitions of the buttons

and menu options that are available on the Main Menu screen.

Table 2: Buttons and menu options on the Main Menu screen

Button or

Menu Option Definition

New Session enables you to start a new programming

session with a patient.

Last Session allows you to resume the last programming

session.

Intra-Op allows you to perform intraoperative testing.

During intraoperative testing, programs will not be

uploaded from or downloaded to the patient programmer or

MTS system.

Print Last Session allows you to print the last programming

session.

Patient List displays patient records.

View Demo enables you to see a demonstration of the

software without having a device connected to the Rapid

Programmer system.

Tools

Within the Tools menu, you can restore the database, copy

log fi les, reset the Rapid Programmer system, and reinstall

the Rapid Programmer system software.

Settings

Within the Settings menu, you can change preferences for

the following settings: backlight, brightness, clock, power,

regional, screen, and volume.


Adjusting Backlight Settings

While you are working with the programmer, backlighting illuminates the

screen. To help preserve the battery capacity, you can set the backlight

to turn off after a period of inactivity. You can adjust this setting for the

programmer when it operates on battery power or on external power. To

adjust backlight settings, follow these steps:

1. On the Main Menu screen, tap Settings, then Backlight. The Backlight

screen appears.

Figure 15: The Backlight screen

2. Do one of the following:

To change settings for battery power, tap the Battery Power tab.

To change settings for external power, tap the External Power tab.

3. To turn off the backlight after a period of inactivity, ensure that the

first check box is selected, and then tap the list to select the amount

of time before the backlight turns off.

4. Adjust other settings as desired by tapping the appropriate check boxes

and lists.


Adjusting Screen Brightness

You can adjust the level of brightness of the backlighting on the screen for the

programmer when it operates on battery power and external power. A lower

brightness level help preserve battery capacity when operating the programmer

on battery power. To adjust the screen brightness , follow these steps:

1. On the Main Menu screen, tap Settings, then Brightness. The

Brightness Level screen appears.

Figure 16: The Brightness Level screen

2. Tap and drag the desired slider to adjust the brightness level for

battery power or external power.

NOTE: A light sensor on the front of the programmer detects the environmental light level

and automatically adjusts the screen brightness in a small range based on the current

setting.


Setting the Time and Date

The time and date appear on printable reports. To set the time and date for

your home location or a visited location, follow these steps:

1. On the Main Menu screen, tap Settings, then Clock. The Clocks &

Alarms screen appears.

Figure 17: The Clocks & Alarms screen

NOTE: When you fi rst start using the programmer or if you remove the programmer battery ,

you may be prompted to set the time and date, which means that the Clocks & Alarms

screen automatically opens.


To set the time and date for your home location, tap the Home

option button.

To set the time and date for a visited location, tap the Visiting

option button.


3. To adjust the time zone, tap arrow beside the time zone box and select

the correct zone from the list that appears.

4. To adjust the time, tap the hour, minute, second, or morning or

afternoon designation, and then tap the increase and decrease buttons

to adjust the value.

5. To adjust the date, tap the arrow beside the date box to expand a

calendar, and do any of the following:

To adjust the month, tap the name of the month and select the

correct month from the list that appears.

To adjust the year, tap the year and then tap the increase and

decrease buttons.

To adjust the day, tap the correct day in the calendar.

6. Tap the Home or Visiting option button to select the time that you want

to use.

Checking the Programmer Battery Status

To check the status of the programmer battery , follow these steps:

1. On the Main Menu screen, tap Settings, then Power. The Power screen

appears.

2. Ensure that the Battery tab is selected to view the amount of power

remaining in the battery .

Figure 18: The Power screen showing battery power information


Adjusting the Automatic Shutoff Settings

You can set the programmer to turn off after a period of inactivity, and you

can adjust this setting for the programmer when it operates on battery power

or on external power. To adjust these automatic shutoff settings, follow

these steps:

1. On the Main Menu screen, tap Settings, then Power. The Power screen

appears.

2. Tap the Advanced tab.

Figure 19: The Power screen showing automatic shutoff settings

3. To set the automatic shutoff time on battery power, ensure that the

battery power check box is selected, and then tap the list to select the

amount of time before the programmer turns off.

4. To set the automatic shutoff time for external power, tap the external

power check box, and then tap the list to select the amount of time

before the programmer turns off.


Calibrating the Touch Screen

The touch screen display will occasionally require calibration to increase

the accuracy of screen taps. To calibrate the touch screen, do the following

action:

On the Main Menu screen, tap Settings, then Screen. The align screen

screen appears. Follow all on-screen instructions carefully, and ensure

that the stylus touches the center of the target graphic for proper

calibration.

NOTE: The Main Menu screen appears automatically after you are fi nished.

Figure 20: The align screen screen


Adjusting the Volume

To adjust the volume of the programmer, follow these steps:

1. On the Main Menu screen, tap Settings, then Volume. The Sound

screen appears.

2. Tap and drag the slider to the desired volume.

Figure 21: The Sound screen


Starting the Demo

The demo feature allows you to practice creating a program for systems

without having an actual patient or device. To start a demo session, follow

these steps:

1. From the Main Menu screen, tap . The Demo Session dialog box

appears.

Figure 22: The Demo Session dialog box

2. In the Select a demo list, tap the type of device that will be

represented in the demo.

3. Tap OK. The demo simulates a postoperative programming session.

Refer to sections in “Intraoperative and Postoperative Programming”

for instructions on how to select lead configurations and program in

demo mode.

NOTE: While you can perform the demo with any of the available lead confi gurations, only

specifi c lead confi gurations contain default programs, which have demonstration program

parameters and test log data. If you select a confi guration other than one of these specifi c

lead confi gurations, a Lead Change message appears. When you tap OK in this message,

all the default programs are deleted for the demo session.


Intraoperative and Postoperative Programming

This section provides instructions and information about intraoperative and

postoperative testing and programming . Before programming with a patient,

you may want to view the demo to familiarize yourself with the programmer

functions (refer to “Starting the Demo ”).

NOTE: To keep the CF card connected to its cable, handle all cables with care while

programming .

Buttons and Icons on the Programming Screens

The following table provides defi nitions for buttons and icons that you may

encounter while testing and programming .

NOTE: Not all buttons or icons will be available on all screens. You can also access the

defi nitions of on-screen buttons and icons by tapping the help icon ( ) in the upper right-

hand corner of many of the screens.

Table 3: Buttons and icons on the programming screens

Button or Icon Definition

Access defi nitions of on-screen buttons and icons.

Turn the on-screen keyboard on or off.

Add a new program.

Copy the selected program.

Edit the selected program.

Delete the selected program or stimset on the Programs screen.

Print a report or list.

Balance the selected program.

Automatically return the amplitude to the programmed perception value

while steering stimulation. (When this feature is active, the icon on this

button is blue.)



Use the MultiSteering programming feature to steer the electrical fi eld up.

Use the MultiSteering programming feature to steer the electrical fi eld down.

Use the MultiSteering programming feature to steer the electrical fi eld left.

Use the MultiSteering programming feature to steer the electrical fi eld right.

Shift the electrode polarities up.

Shift the electrode polarities down.

Increase the value of a parameter (Increase button).

Decrease the value of a parameter (Decrease button).

Change the polarity of the IPG can.

Set the target, comfort, or perception amplitude to the current amplitude

level.

Ramp the current amplitude to the target, comfort, or perception level.

Map where the patient feels stimulation.

Stop stimulation immediately for all active stim sets.

Add a new stimset or burst pulse to the program.

Delete a stimset or burst pulse from the program.

Turn the selected stimset on.

Turn the selected stimset off.

View the test log.



Check impedance on the lead confi guration.

Edit the timing and magnet mode of the program.

Activate or inactivate BurstDR™ stimulation programming . (When this

feature is active, the icon on this button is blue.)

Starting an Intraoperative Testing Session

To start intraoperative testing, follow these steps:

1. Ensure the system is connected to the patient programmer or MTS™

unit to be programmed.

NOTE: If testing using a patient programmer, ensure that the patient programmer is

communicating with the generator before starting the testing session. For instructions on

communicating with the generator, refer to the clinician’s manual or user’s guide for the

appropriate system.

NOTE: Once the system has successfully established communication with the device to

be programmed, the screen of the patient programmer or MTS unit displays COMPUTER

COMMUNICATIONS.

2. On the Main Menu screen, tap . The Select Lead dialog box

appears.


3. In the Select a lead configuration for intra-operative testing list, tap the

appropriate lead configuration.

Figure 23: The Select Lead dialog box

4. Tap OK. The Testing screen appears.

Figure 24: The intraoperative testing screen


5. Perform intraoperative testing.

To enhance the speed of an intraoperative testing session, the testing

functions are limited to the following. Refer to the corresponding sections in

this manual for instructions on performing these functions.

Setting electrode polarities

Adjusting amplitude and amplitude step size

Adjusting frequency and pulse width

Measuring impedance

Using the MultiSteering™ programming feature


Starting a New Programming Session or Resuming the Previous Session

To start a new programming session or resume the previous session, follow

these steps:

1. Ensure the system is connected to the patient programmer or MTS™

unit to be programmed.

NOTE: Before programming a patient, ensure you are not in demo mode.

NOTE: If programming using a patient programmer, ensure that the patient programmer

is communicating with the generator before starting the programming session. For

instructions on communicating with the generator refer to the clinician’s manual or user’s

guide for the appropriate system.

NOTE: Once the system has successfully established communication with the device to

be programmed, the screen of the patient programmer or MTS unit displays COMPUTER

COMMUNICATIONS.

2. On the Main Menu screen, tap one of the following as appropriate.

Begin programming a new patient or a different device,

or program the same device and discard the unsaved

programming information from the previous session.

Return to the last programming session.

NOTE: Do not use this option when using the system to program

a different patient or if a change has been made to the patient

programmer or MTS unit while disconnected from the system.

3. If a message appears stating, “All information from the prior session

will be deleted. Continue?”, tap OK.

4. When using the MTS system, if a message appears stating, “Is this a

new patient?”, tap Yes to delete all the programs on the MTS system or

tap No to keep the existing programs. The Uploading Programs screen

and then the Programs screen appears. The Programs screen displays

the Device Info tab.

NOTE: When the “Is this a new patient?” message appears, if you tap Yes by mistake,

you can prevent the programs on the MTS system from being deleted by tapping Cancel

Session on the Programs screen.


Figure 25: The Programs screen

5. If needed, in the Device Info tab, tap (edit) next to the patient’s name.

The Patient Details screen appears, which displays the Patient Info and

Comments tabs.

NOTE: Tap in the bottom of the screen to display the on-screen keyboard. Tap the

123 button in the upper left corner of the keyboard to switch between numbers and

letters.

Figure 26: The Patient Details screen


6. In the Patient Info and Comments tabs, use the on-screen keyboard to

enter information in the boxes as needed.

7. When finished, tap Save.

Selecting the Lead Configuration

To select the patient’s lead confi guration for postoperative programming ,

follow these steps:

On the Device Info tab on the Programs screen, select the patient’s

lead configuration from the Lead Configuration list.

NOTE: If single lead is inserted into the top header of a dual-header generator, you should

not select a single lead confi guration. Instead select the dual-lead option (indicated

by “x2”) of the lead you want to program. Program the lead numbered 9 to 16 (for an

Octrode™ lead) or 5 to 8 (for a Quattrode™ lead).

Resetting the Hours Used for the MTS System

When programming the MTS™ system for a new patient, you can reset the

usage counter to zero.

To reset the hours used, follow these steps:

1. On the Device Info tab on the Programs screen, tap (reset).

2. When the Confirm Reset message appears, tap OK.

Figure 27: The Confi rm Reset message


Adding a New Program

To add a new program, follow these steps:

1. On the Programs tab on the Programs screen, tap . The Testing

screen appears.

2. Set the desired parameters.

1

92

5

3

6

4

7 8

10

11

13

15

12

14

16

Figure 28: Features of the Testing screen

Legend:

1. Shifts the electrode polarities or the

electrical fi eld

2. Automatically returns the amplitude to

the programmed perception level when

steering stimulation

3. Adds a new stim set to the program

4. Deletes the current stimset

5. Switches to BurstDR™ stimulation

programming mode

6. Shows the test log

7. Checks impedance on the electrode

confi guration

8. Edits the timing and magnet mode of

the program

9. Selects the stim set for testing.

10. Turns the stim set on or off

11. Sets the comfort amplitude to the

current level.

12. Ramps the current amplitude to the

comfort level

13. Sets the perception amplitude to the

current level

14. Ramps the current amplitude to the

perception level

15. Maps the location of perceived

stimulation

16. Stops stimulation on all stim sets

Copying a Selected Program

To copy a program, follow these steps:

1. On the Programs tab on the Programs screen, select the program from

the list that you want to copy.

2. Tap . The duplicated program appears as the next available program

number.


Editing a Selected Program

To edit a program , follow these steps:

1. On the Programs tab on the Programs screen, select the program from

the list that you want to edit.

2. Tap . The Testing screen appears.

3. Edit the desired parameters.

Deleting a Selected Program, Stim Set, or Burst Pulse

To delete a program or stim set , follow these steps:

1. On the Programs tab of the Programs screen, select the program or

stim set from the list that you want to delete.

2. Tap . The Confirm Delete message appears.

3. Tap OK.

NOTE: If you select and delete the pulses of a BurstDR™ stimulation program on the

Programs screen, you will delete the entire program.

NOTE: You can also delete a stim set or a burst pulse while viewing it on the Testing

screen. While on the Testing screen, tap the number of the stim set or burst pulse you

want to delete, tap , and follow the on-screen prompts.

Figure 29: The Confi rm Delete message


Switching Between Tonic Mode and BurstDR™ Stimulation Mode

Some systems allow you to create and modify two types of programs:

BurstDR™ stimulation program. A program where the stimulation

frequency consists of a group of pulses in rapid succession followed

by a period without pulses before repeating the group. This type

of program is available only on some systems that the Rapid

Programmer™ system supports.

Tonic program . A program where the stimulation frequency consists

of a single, repeating pulse. This program type is available on all

neurostimulation systems that the Rapid Programmer system supports.

If the system you are programming is capable of BurstDR stimulation,

you can switch to BurstDR stimulation programming mode on the Testing

screen.

NOTE: When creating a new program, you start programming in tonic programming mode by

default.

NOTE: When you switch between BurstDR stimulation mode and tonic mode, all programmed

values reset to default except the electrode confi guration.

To switch between tonic mode and BurstDR stimulation mode, follow these

steps:

1. On the Testing screen, tap . When BurstDR stimulation mode is

active, the icon turns blue, the screen background turns blue, and

the Testing screen displays the features for BurstDR stimulation

programming (see the following figure).

2. To return to tonic mode, tap . When BurstDR stimulation mode is

inactive, the icon turns gray, the screen background turns white, and

the Testing screen displays the features for tonic programming .


9

11

7

10

8

12 13

5

1

3

2

6

4

Figure 30: Features of the Testing screen

in BurstDR stimulation mode

Legend:

1. Displays the overall frequency of the

BurstDR stimulation program

2. Displays the frequency of each burst

pulse in a pulse group

3. Sets the target amplitude to the current

level

4. Ramps the target amplitude to the target

level

5. Maps the location of perceived

stimulation

6. Stops stimulation on all stim sets

7. Adds a burst pulse to the pulse group

8. Deletes a burst pulse

9. Displays the number of burst pulses

10. Turns stimulation on or off

11. Inactivates BurstDR stimulation

programming mode

12. Checks impedance on the electrode

confi guration

13. Edits the timing and magnet mode of the

program

Configuring Electrode Polarities

Individual electrodes on a lead can be set to positive (anode), negative

(cathode), or neutral. The IPG (also called a “can”) also may be confi gured

as positive (anode) or neutral.

NOTE: The IPG can be used as an anode only for tonic programs.

NOTE: When the IPG is used as an anode, lead polarities can be only negative or neutral. All

lead polarities that are confi gured as anodes are automatically set to neutral.

NOTE: If you manually change polarities while stimulation is active, stimulation turns off.

If you manually change polarities after you have set values for perception and comfort

amplitude, a Reset Parameters message appears. If you tap OK, the perception and comfort

amplitude values reset to zero and the stimulation map is erased.

To confi gure electrode polarities, follow these steps:

1. On the Testing screen, tap a numbered electrode button on the lead

diagram. The first tap changes a neutral electrode to a negative polarity

(cathode); the second tap changes the electrode to a positive polarity

(anode); and the third tap returns the electrode to a neutral state.


2. To use the IPG as an anode, tap in the lower left of the Testing

screen. This icon turns red and shows a plus sign when activated. To

return the IPG to a neutral state, tap .

Adjusting Pulse Width

During intraoperative testing and postoperative testing for new programs,

the PW (pulse width ) box on the Testing screen displays default values,

which are determined by the system type and programming mode (tonic or

BurstDR™ stimulation).

To change values for pulse width , do either of the following:

Tap the Increase/Decrease buttons next to the PW box.

Tap the PW box, and then tap a value in the drop-down list.

Adjusting Frequency for Tonic Programs

During intraoperative testing and postoperative testing for new tonic

programs, the Freq (frequency ) box on the Testing screen displays system

default values

To change values for frequency , do either of the following:

Tap the Increase/Decrease buttons next to the Freq box.

Tap the Freq box, and then tap a value in the drop-down list.

Adjusting Frequency for BurstDR™ Stimulation Programs

BurstDR™ stimulation programs have two frequency values that you can

set: the overall frequency (Burst Rate) and the frequency of each individual

pulse in a pulse group (Intra-burst). During postoperative testing for new

BurstDR stimulation programs, the Burst Rate and Intra-burst boxes on the

Testing screen display system default values.

To change the frequency values for a BurstDR stimulation program, do

either of the following:

Tap the Increase/Decrease buttons next to the respective box.

Tap the respective box, and then tap a value in the drop-down list.


Adjusting Amplitude and Step Size

On the Testing screen, you can adjust amplitude and step size. Amplitude is

the strength of the electrical pulse that is delivered from the lead. Step size

is the increment at which amplitude will change when you adjust amplitude

during programming. Programs that use a higher amplitude setting deplete

the neurostimulation system battery faster.

NOTE: At any time during testing, you can immediately stop the patient’s stimulation by

tapping .

NOTE: When the generator reaches its energy limit , the Energy Limit dialog box appears. To

reduce the energy output of the generator, tap ok and follow the on-screen suggestions.

NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow. To

reduce the output of the generator, try reducing the amplitude or pulse width or try setting

additional anodes or cathodes on the lead confi guration.

To adjust amplitude, follow these steps:

1. If stimulation is off, tap the Increase button next to the Amp box to

start stimulation.

2. To change the step size, tap the Increase/Decrease buttons next to the

Step box, or tap the Step box and then tap a value in the drop-down

list.

3. Tap the Increase/Decrease buttons next to the Amp box to increase or

decrease stimulation accordingly.

Setting Perception and Comfort Amplitudes for Tonic Programs

To complete a tonic program during postoperative programming , you

must set values for perception (Perc) and comfort (Comf) amplitudes for

each stim set. The perception amplitude is the value at which the patient

fi rst feels stimulation. The comfort amplitude is the value at which the

stimulation feels comfortable to the patient.




NOTE: During programming , if you change electrode polarities after you have set the values

for perception and comfort amplitude, the perception and comfort amplitude values will reset

to zero.


NOTE: Once you have set the comfort and perception amplitudes, you can tap next to the

Comf and Perc boxes to ramp the amplitude to the respective comfort or perception value.

To set a patient’s perception and comfort amplitudes, follow these steps:

1. Tap the Increase/Decrease buttons next to the Amp box to reach the

patient’s perception amplitude.

2. To set the perception amplitude, tap next to the Perc box.


patient’s comfort amplitude.

4. To set the comfort amplitude, tap next to the Comf box.

Setting the Target Amplitude for BurstDR™ Stimulation Programs

To complete a BurstDR™ stimulation program during postoperative

programming, you must set the value for the target amplitude . The target

amplitude is the value at which stimulation feels comfortable to the patient.




NOTE: During programming , if you change electrode polarities after you have set the value

for target amplitude , the target amplitude value will reset to zero.

NOTE: Once you have set the target amplitude, you can tap next to the Target box to

ramp the amplitude to the target value.

To set a patient’s target amplitude , follow these steps:


patient’s target amplitude.

2. Tap next to the Target box.

Adding a Stim Set or a Burst Pulse to a Program

To add another stim set to a tonic program or another burst pulse to a

BurstDR™ stimulaton program , follow these steps:

1. On the Testing screen, tap .

2. Set the electrode polarities and other parameters as needed.


Using the MultiSteering Programming Feature

The MultiSteering ™ programming feature provides a simplifi ed method for

shaping and fi ne-tuning the electrical fi eld in real time. During testing, certain

electrode combinations can be shifted while stimulation remains active.

NOTE: This programming feature is available only for tonic programs.

NOTE: When programming dual Octrode™ leads, you can steer stimulation laterally between

the two leads. Confi rm that the electrodes on the patient’s leads are aligned as they appear

on the Testing screen.

NOTE: Because some nerve fi bers may be more sensitive to electrical fi elds than others, you

should adjust the amplitude to the patient’s perception level (Perc) each time before steering

to the next combination.

NOTE: If you have set the Perc value and the return-to-perception button ( ) is active,

the system automatically reduces the amplitude to the perception level each time you steer

stimulation. If the button is active, the icon is blue.

NOTE: If , , , or appear dimmed, it means that the selected electrode combination

cannot be steered in that direction. Try adding or removing polarities until the MultiSteering

buttons become active.

NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow

and MultiSteering programming will be temporarily unavailable. To use MultiSteering

programming, reduce the output by adjusting pulse width or amplitude.


To use the MultiSteering programming feature

Tap , , , or to steer the stimulation through a set of optimized

electrode combinations designed to incrementally shift the stimulation.

2 3

4

5

1

Figure 31: MultiSteering programming

buttons available on the Testing screen

Legend:

1. Shift up

2. Shift left (dimmed)

3. Shift right

4. Shift down

5. Return the amplitude to the

programmed perception value

(when active)

Creating a Stimulation Map

During testing, you can create a stimulation map that shows where the

patient feels stimulation with a specifi c stimulation set for tonic programs

or with a pulse group for BurstDR™ stimulation programs. The stimulation

map appears as an icon on the user’s patient programmer or MTS™ unit.


To create a stimulation map , follow these steps:

1. On the Testing screen, tap . A screen appears with a graphic

representation of the human body and the Draw option selected.

Figure 32: The stimulation map screen

2. Tap the areas on the graphic that correspond to the areas where the

patient feels stimulation. The tapped areas are highlighted in green.

3. To remove a highlighted area, tap Erase and then the area on the

graphic.

4. To save the stimulation map , tap Done.


Using the Dynamic MultiStim Programming Feature

The Dynamic MultiStim™ programming feature allows you to actively turn

a stim set on or off to assess how well the stim sets work separately and

together as a program.

NOTE: This programming feature is available only for tonic stimulation programs.

NOTE: During Dynamic MultiStim program ming, all stim sets must have the same frequency .

If you change frequency in one stim set, frequency automatically changes in the program’s

other stim sets.

NOTE: When you add a stim set , the amplitude of all the stim sets returns to zero.

The following list describes the stim set buttons used for Dynamic

MultiStim programming :

1When the number of a stim set is blue, you are viewing that

stim set. Tap the number to select the stim set and adjust

that stim set’s settings.

When the amplitude is more than zero (active) for that stim

set, the Stim Set button is “on” (green). If stimulation is

off, tap the Stim Set button to ramp the amplitude to the

last value that was reached for the stim set during the same

testing session.

When amplitude is zero for that stim set, the Stim Set button

is “off.” If stimulation is more than zero (active) for a stim

set, tap the Stim Set button to turn off stimulation.


2 3

1

Figure 33: Buttons for Dynamic MultiStim

programming

Legend:

1. Stim set selected

2. Stim set button on

3. Stim set button off


Viewing the Test Log

The test log allows you to view stim sets that have been tested on the

patient and to add or replace them within the current program.

NOTE: The test log is available only for tonic stimulation programs.

NOTE: Test log data is only kept within a single programming session. If you start a new

session, the test log contains only the stim sets that were uploaded from the device.

NOTE: On the Test Log screen (see the following fi gure), if you select the Show valid stimsets

only check box, the test log will show only the stim sets that are compatible with the present

program. For program compatibility, see the clinician’s manual for the appropriate device.

To view the test log , do either of the following:

From the Testing screen, tap .

From the Programs tab on the Programs screen, select the desired stim

set from the list, and tap .

Figure 34: The Test Log screen


To Add a Stim Set From the Test Log

You can select a stim set from the Test Log screen to add to the current

program.

NOTE: To be able to add a stim set to an existing program, the parameters of the program

must match the device’s capabilities and the program must not contain its maximum number

of stim sets, which is determined by the device type. If your parameters are outside of

acceptable ranges for the device, an error message appears.

To add a stim set from the test log, follow these steps:

1. On the Test Log screen, tap the Add tab.

2. Select a stim set from the list.

3. Tap Add.

To Replace a Stim Set From the Test Log

You can also replace the current stim set with a selected stim set from the

Test Log screen.

To replace a stim set from the test log, follow these steps:

1. On the Test Log screen, tap the Replace tab.

2. Select a stim set from list.

3. Tap Replace.

Measuring Impedance

During testing, you may want to periodically measure the impedance on the

electrode array as a diagnostic tool to ensure that current is fl owing through

the system properly. Impedance measurements may help you troubleshoot

issues with the neurostimulation system.

NOTE: If the parameter boxes on the Testing screen turn yellow, your impedance

measurement will probably be high. See the “Troubleshooting” section for more information.

To measure impedance for the programmed electrode array, follow these

steps:

1. On the lower left corner of the Testing screen, tap . The Impedance

Results dialog box appears (see the following figure, left).


2. If the option is available, tap Diagnostics in the Impedance Results

dialog box to get diagnostic details for the entire lead configuration.

The Diagnostic Summary details the condition and the impedance

values for each electrode by number (see the following figure, right). If

desired, tap Print to print a lead diagnostics report (see “Printing ”).

Figure 35: The Impedance Results dialog box Figure 36: The Diagnostic Summary screen

3. Refer to the applicable clinician’s manual for information on

interpreting the results of the impedance measurement.

4. When you are finished, do one of the following to return to the Testing

screen:

In the Impedance Results dialog box, tap Done.

On the Diagnostic Summary screen, tap OK.


Modifying IPG Modes

From the Edit Modes screen, you can modify IPG modes by performing the

following functions:

Set the magnet mode

Set the program mode

Set the on and off times for cycle and bolus mode s

Set the ramp time for continuous and bolus modes

To modify IPG modes, follow these steps:

1. On the Testing screen, tap . The Edit Modes screen appears.

2. Modify the settings as desired. The following subsections provide more

information about using these settings.

3. When you are finished, tap Save.

Figure 37: The Edit Modes screen

To Set the Magnet Mode

The magnet mode settings control how the IPG responds when it senses a

magnet. To set the magnet mode , tap the desired option button:

Off, which means the IPG will turn off when it senses a magnet

On/Off, which means the IPG will toggle between on and off each time

it senses a magnet


To Set the Ramp Time

Ramp time is the approximate number of seconds that the IPG takes when

starting stimulation to arrive at the perception amplitude for tonic programs

or the target amplitude for BurstDR™ stimulation programs. Ramp time is

saved to the IPG; it is not the ramp time that you use while programming .

You can adjust the ramp time for the IPG when it is set to continuous

or bolus mode (see the “To Set the Program Mode” section for more

information). The default ramp time is 4 seconds.

To change the ramp time, tap the Increase/Decrease buttons next to

the Ramp Time box.

To Set the Program Mode

You can set the stimulation mode of a program. The following table provides

defi nitions of the three program modes that may be available.

Table 4: Defi nitions of IPG Program Modes

Mode Definition

Continuous Stimulation is delivered continuously while the IPG is on and the

program is running.

Cycle Stimulation is on for a programmed amount of time (on time) and off for

a programmed amount of time (off time). The cycle alternates between

on and off time until the IPG is turned off or the program is stopped.

Bolus Stimulation is on for a programmed amount of time (on time) and then

enters a phase of off time. During the off time phase, stimulation cannot

be restarted. After the off time has passed, stimulation must be restarted

manually.

To set the program mode , follow these steps:

1. Under Program Mode, tap the desired check box. If you tap Bolus or

Cycle , the On Time and Off Time timer boxes become available.

2. Tap the Increase/Decrease buttons beside the timer boxes to set the on

and off phase times.

NOTE: You can set the on and off cycle times to a maximum of 24 hours and a minimum of

5 seconds.

NOTE: You can set the on and off bolus times to a maximum of 18 hours and a minimum of

1 second.


Saving a Program

During postoperative programming , you must save a program before

downloading it.

To save the program, tap Save on the Testing screen.

NOTE: During intraoperative testing, you do not need to save the program. To exit an

intraoperative testing session and return to the Main Menu screen, simply tap Done on the

Testing screen.

NOTE: If any parameters of a stim set are incomplete for a program, a Stimset Error

message appears when you try to save the program. To correct this issue, ensure that you

have confi gured valid electrode polarity combinations and have set values for comfort and

perception amplitude on all stim sets.

Using the Active Balancing Programming Feature

The Active Balancing ™ programming feature allows you to individually

adjust the amplitudes of each stim set within a program, which helps

balance the feeling of stimulation that is delivered to a patient.

NOTE: This programming feature is available only for tonic stimulation programs.

To balance a program, follow these steps:

1. On the Programs tab on the Programs screen, select a program from

the list.

2. Tap . The Balancing screen appears.


Figure 38: The Balancing screen

3. Tap the Increase button beside the master amplitude box. The

amplitude ramps up to the perception value (Perc).

NOTE: To stop stimulation, tap Stop. This button turns off the master amplitude but does

not change the slider values.

4. Tap the Increase/Decrease buttons to adjust the master amplitude until

the patient indicates that stimulation is comfortable.

5. Tap above or below the slider to increase or decrease the amplitude

level of a stim set.

NOTE: To reset all sliders to zero, tap Reset.

6. If the program contains more than four stim sets, tap More to display

the remaining stim sets, and adjust the stim sets if necessary.

7. Tap Save.


Downloading Programs

After completing a programming session, you can download programs to the

patient programmer or MTS™ unit that is communicating with the system.

All programs are downloaded at once.

To download programs, follow these steps:

1. On the Programs tab of the Programs screen, select the program from

the list that will be the active program on the patient programmer or

MTS unit.

Figure 39: A program selected on the Programs screen


2. Tap Download, and then tap OK in the Replace Programs message that

appears (see the following figure). The Downloading Programs screen

appears; and after the programs have been downloaded to the patient

programmer or MTS unit, the Main Menu screen appears.

NOTE: If downloading programs to an IPG, ensure that the programs have fi nished

downloading before moving the programming wand from over the IPG site.

Figure 40: The Replace Programs message

3. To ensure that the device has completed the download process, turn the

patient programmer or MTS unit off and then on again.

Overriding the Usage Range for Amplitude

Before downloading programs, you can override the usage range for

amplitude. The Override Usage Range screen allows you to override the

tested amplitude range by increasing the maximum tolerable amplitude or

decreasing the perception amplitude setting by up to 25 percent without

testing stimulation on the patient.

NOTE: The feature to override the usage range is available only for tonic stimulation

programs.

NOTE: If you override the amplitude usage range of a MultiStim ™ program that has been

balanced using the Active Balancing™ programming feature, you may need to rebalance the

program (see “Using the Active Balancing Programming Feature”).


To override the usage range

1. On the Programs tab of the Programs screen, tap and hold Download

for 5 seconds until the Override Usage Range screen appears.

Figure 41: The Override Usage Range screen

2. Tap the Increase/Decrease buttons to change the maximum tolerable

amplitude and perception amplitude percentages as desired.

3. Select one or more program check boxes to which you want to apply

the changes.

-OR-

Select the Apply to all programs check box to select all check boxes.

4. Tap Download, and then tap OK in the Replace Programs message that

appears. The programs are downloaded to the patient’s device.


Managing Patient Records

The Rapid Programmer™ system allows you to manage patient records by

adding, editing, or deleting patient data. To manage patient data, ensure

that a database card that is compatible with the Rapid Programmer system

is inserted.

Buttons and Icons on the Patient Database Screens

The following table provides defi nitions for buttons and icons that you may

encounter while managing patient records.

NOTE: Not all buttons or icons will be available on all screens. You can also access the

defi nitions of on-screen buttons and icons by tapping the help icon ( ) in the upper right-

hand corner of many of the screens.

Table 5: Buttons and icons on the patient database screens


Access defi nitions of on-screen buttons and icons.

Turn the on-screen keyboard on or off.

Add a new patient.

Edit a selected (highlighted) patient.

Combine two checked patients into one record.

Delete checked patients.

Print the patient list (on the Patients screen).

Print the programs for the patient (on the Patient Details screen).

Export checked patient records to the database card .


Accessing the Patient Database

To access the patient database, you must enter a password . Contact

Technical Support for the default password related to your software version.

Once you have the password , follow these steps:

1. From the Main Menu screen, tap . The Enter Password screen

appears.

Figure 42: The Enter Password screen displaying the on-screen keyboard

2. If necessary, tap at the bottom of the screen to display the

on-screen keyboard. Tap the 123 button in the upper left corner of the

keyboard to switch between symbols and letters.

3. Enter the password in the Enter Password box. Passwords can be up

to 11 characters. See “Changing the Password for Viewing Patients” to

change the password .

NOTE: The password is case sensitive.


4. Tap OK. The Patients screen appears. You can sort list items by

tapping the column heading.

5. If desired, tap to print the patient list (see “Printing ”).

Figure 43: The Patients screen


Changing the Password for the Patient Database

To change the password for the patient database, follow these steps:

1. On the Patients screen, tap Database, and then tap Change Password.

The Change Password screen appears.

2. Use the on-screen keyboard to fill in the boxes, and tap OK when

finished.

Figure 44: The Change Password screen


Adding a Patient to the Database

To add a patient to the database, follow these steps:

1. From the Patients screen, tap . The Patient Details screen appears.


2. On the Patient Info and Comments tabs, tap a box you want to

complete and enter the information using the on-screen keyboard.

3. If desired, tap to print the selected patient’s neurostimulation record

(see “Printing” ).

4. Tap Save to save the patient’s information and return to the Patients

screen.


Editing a Patient’s Information

To edit a patient’s information in the database , follow these steps:

1. From the list on the Patients screen, tap the name of the patient you

want to edit. The selected name is highlighted.

Figure 46: Highlighting a patient on the Patients screen

2. Tap . The Patient Details screen appears.



3. Using the on-screen keyboard, edit the information on the Patient Info

and Comments tabs.

4. Tap Save to save the patient’s information and return to the Patients

screen.

Deleting a Patient From the Database

To delete a patient from the database, follow these steps:

1. On the Patients screen, select the check boxes that correspond with

the patients whom you want to delete (see the following figure, left). To

select all patients, tap in the header. Tap again to deselect all

patients.

2. Tap , and then tap OK when the Confirm Delete message appears

(see the following figure, right).

Figure 48: Selecting patient check boxes

on the Patients screen

Figure 49: The Confi rm Delete message


Combining Patient Data

The combining patient data feature allows you to combine information from

two patient records into one record. The patient name from only one patient

is kept, and only the most recent session of the two patients is retained. In

order for the two patient record s to be combined, either must be true:

The generator in each record must share the same model number and

serial number

The generator in one of the patient records must not have a model

number and serial number assigned

To combine patient data, follow these steps:

1. On the Patients screen, select the check boxes from the list for the two

records you want to combine (see the following figure, left).

2. Tap . The Combine Patients screen appears (see the following figure,

right).

Figure 50: Selecting patient check boxes

on the Patients screen

Figure 51: The Combine Patients screen

3. Select which patient’s record will store the combined information by

tapping the button next to that patient’s name.

NOTE: The patient information from the most recent session will be saved.

4. Tap OK. The records are combined and the unselected patient record is

deleted.


Merging and Copying Patient Database s

The merge feature allows you to combine two patient databases from two

separate database cards. The copy feature allows you to copy the patient

database from one database card to another.

To merge or copy data, follow these steps:

1. In the lower left corner of the Patients screen, tap Database, and then

tap either Merge or Copy.

2. When the Confirm Merge or Confirm Copy message appears, tap OK,

and follow the on-screen instructions.

Figure 52: The Database menu on the Patients screen


Exporting Patient Records

On the Patients screen, you can export patient records to a database card as

a fi le (PatientExport.txt) that can be opened on a computer using a database

card reader.

CAUTION: When viewing files on the database card with a database

card reader, view only the PatientExport.txt file and do not edit or

delete any other files on the card. Otherwise, you may inadvertently

delete the database from the card.

To export patient records, follow these steps:

1. Ensure that the database card containing the records is inserted in the

programmer.

2. From the list on the Patients screen, select the check boxes of the

patient records to export.

3. Tap . The Confirm Export message appears (see the following figure,

left).

4. Tap OK.

5. When the Export Complete message appears, tap ok (see the following

figure, right).

Figure 53: The Confi rm Export message Figure 54: The Export Complete message


Restoring a Database

The programmer automatically backs up the database before every major

database operation. The programmer stores up to seven daily backup fi les

that are captured at the start of the fi rst session of each day, as well as

up to three monthly backup fi les that are captured at the start of the fi rst

session of the month. If something unwanted happens to the database, you

can try to restore it from one of these backup fi les.

To restore a database , follow these steps:

1. Ensure that the database card containing the patient database is

inserted.

2. On the Main Menu screen, tap the Tools menu, and then tap Restore

Database. The Restore Database screen appears.

Figure 55: The Restore Database screen

3. From the list of available files, tap the date of the file you want to

restore.

4. Tap OK. When the Restore Complete message appears, tap ok to return

to the Main Menu screen.


Printing

You may print programming and database data from the Rapid

Programmer™ system using the St. Jude Medical Bluetooth® printer (Model

3823).

NOTE: The Rapid Programmer system can print to the Bluetooth printer from a distance up

to 10 m (33 ft).

NOTE: It may take up to a minute to start printing after you tap Print.

Types of Printable Reports

The following table lists the types of reports you can print and the locations

from which you can print them. To see full examples and to learn more

about the information contained on these reports, see Appendix A.

Table 6: Types of printable reports

Report Type Description Print From...

Neurostimulation

record

Contains a record of all programs,

as well as generator and lead

information, for a selected patient

The Main Menu screen (prints

the record from the last testing

session only).

The Programs tab on the

Testing screen.

The Patient Details screen

for a selected patient in the

database.

Patient list Lists patient names from the

database and the dates of their

last revisions

The Patient History Details screen

in the patient records database.

Lead diagnostics

report

Shows the results of the diagnostic

testing performed on a generator

and leads for a specifi c program

NOTE: This report is available only

for the Eon, Prodigy, Protégé, and

MTS systems.

The Diagnostic Summary screen

after measuring impedance .


Printing a Neurostimulation Record

To print a neurostimulation record , follow these steps:


If printing from the Main Menu screen, tap .

If printing from the Testing screen or Patient Details screen, tap .

2. Ensure that the printer is turned on.

3. On the Print Preview screen, tap Print.

4. If a Multiple Printers Found message appears, tap the box in the

message to open a list of nearby printers, select a printer from the list,

and then tap OK.

5. After you have finished printing, tap Done and turn off the printer.

Figure 56: The Print Preview screen for a neurostimulation record


Printing the Patient List

To print the patient list , follow these steps:

1. On the Patients screen, tap .

2. Ensure the printer is turned on.

3. On the Print Preview screen, tap Print.



and then tap OK.

5. After you have finished printing , tap Done and turn off the printer.

Figure 57: The Print Preview screen for a patient list


Printing a Lead Diagnostics Report

To print a lead diagnostics report , follow these steps:

1. Ensure the printer is turned on.

2. On the Diagnostic Summary screen, tap Print.



and then tap OK.

4. When you have finished printing, tap OK and turn off the printer.

Figure 58: The Diagnostic Summary screen


Cleaning and Maintaining the Rapid Programmer System

This section provides tips and other information to help you clean and

maintain the Rapid Programmer™ system and keep it running its best.

Handling the Programmer

To properly handle the programmer, follow these tips:

Handle the programmer with care. It is a sensitive electronic device

that can be damaged by rough handling (e.g., dropping it on the

ground).

Do not expose the programmer to prolonged direct sunlight.

Use the programmer within a safe range of environmental conditions

(see Appendix B).

Avoid exposing the programmer to sand, dust, and other environmental

hazards.

Keep the programmer away from food and beverages, and avoid doing

things that might get the programmer wet. The programmer is not

waterproof.

If the programmer does get wet, do not use it. Contact Technical

Support for help.

Cleaning the Programmer

To properly clean programmer, follow these tips:

When cleaning or disinfecting the programmer, turn off the programmer

and unplug the power adapter.

Use a soft, dry cloth to remove dust from the screen. Never use glass

cleaners.

Clean the programmer by wiping off the outer surface using a damp,

lint-free cloth and a small amount of mild soap.

Do not submerge the programmer or use a cloth that is soaking wet.

Do not use alcohol, cleaning solutions, or solvents to clean the

programmer. They may damage the surface finishes of the programmer.


Storing and Transporting the Programmer

To properly store and transport the programmer, follow these tips:

If storing the programmer for a month or longer, turn the programmer

off, fully charge the programmer battery , and remove and store the

programmer battery separately to maximize its life.

Store the programmer and the programmer battery in a cool, dry place

(see Appendix B).

Transport the programmer in a carrying case.

If you are carrying the programmer in a briefcase, purse, or any other

carrying case, make sure no objects in the case are pressing on the

device.

Do not put heavy or sharp objects on the programmer.


Troubleshooting

This section provides troubleshooting suggestions for issues you might

have with the Rapid Programmer™ system. For additional information,

call Technical Support. When you call, be ready to give the representative

information about what you were doing when the error occurred and what

error messages appeared.

Troubleshooting Chart

Typically, the Rapid Programmer™ system displays a message for issues

associated with programming patients and managing records. If you are

experiencing issues, check the programmer screen for a message and follow

any instructions it gives to correct the issue. If you still experience the issue

or if you experience an issue without receiving an on-screen message, refer

to the following table for possible causes and solutions.

NOTE: In the following table, the term “programmer” refers to the Rapid Programmer system.

The term “patient programmer” refers to the patient programmer for the neurostimulation

system.

Table 7: Possible causes and solutions for potential issues

Problem Possible Cause Possible Solution

Programmer has

no power or has

lost power.

Programmer’s battery is drained. Recharge the battery using the

power adapter or the car charger.

Programmer’s battery is depleted

or defective.

Replace the battery .

Programmer is damaged or

malfunctioning.

Replace the programmer.

Programmer will

not charge.

Power adapter or car charger

is disconnected from the

programmer.

Connect the power adapter or car

charger to the programmer.

Correct plug adapter (voltage

converter) is not connected to the

power adapter’s plug.

Connect the appropriate plug

adapter (voltage converter) to the

power adapter’s plug.

Power adapter or car charger is

defective.

Replace the power adapter or car

charger.


or defective.



malfunctioning.




Nothing is

displayed on the

screen.

Programmer is off or has timed

out.

Turn on the programmer.

Programmer’s battery is drained. Recharge the battery using the

power adapter or the car charger.


or defective.


Screen is damaged or

malfunctioning.

If the programmer appears to be

powered on but without display,

the screen may be defective.

Contact Technical Support.

Programmer will

not respond to

input.

Programmer has locked up. Perform a soft reset .

Touch-screen interface is damaged

or malfunctioning.


Report will not

print from the

printer (Model

3823).

Printer is off. Turn on the printer.

Printer is out of paper. Add a paper roll to the printer.

Interference is disrupting

Bluetooth communication.

Turn off or remove the source of

the interference.

-OR-

Move away from the interference.

Printer is damaged or

malfunctioning.

Replace the printer.



Programmer is not

communicating

with the IPG.

Programmer is in demo mode. Exit the programming session and

return to the Main Menu screen.

Restart the programming session

by tapping the New Session button

or the Intra-Op button as desired.

Patient programmer is off or has

timed out and is in standby mode.

Turn on the patient programmer.

Ensure that the screen displays

COMPUTER COMMUNICATIONS.

Batteries in the patient

programmer are depleted.

Replace the batteries in the

patient programmer.

Programmer battery is drained. Charge the programmer battery .

IrDA cable is disconnected. Connect the IrDA cable to the

CF card cable and the patient

programmer.

CF card cable is disconnected

or improperly seated in the

programmer

Connect the CF card cable to the

IrDA cable, and properly seat the

CF card cable in the programmer.

NOTE: When removing the CF

card cable, wait about 3 seconds

before reinserting it into the

programmer.

Communication wand is not

connected to the patient

programmer.

Connect the wand to the patient

programmer.

Communication wand is not

directly over the IPG site.

Center the wand directly over the

IPG site.

IrDA cable is damaged or

malfunctioning.

Replace the IrDA cable.

CF card cable is damaged or

malfunctioning.

Replace the CF card cable.

Communication wand is damaged

or malfunctioning.

Replace the wand.

Patient programmer is damaged or

malfunctioning.

Replace the patient programmer.


malfunctioning.




Programmer is not

communicating

with the MTS

system.

Programmer is in demo mode. Exit the programming session and





MTS system is off or has timed out

and is in standby mode

Turn on the MTS system.

Ensure that the screen displays

COMPUTER COMMUNICATIONS.

Batteries in the MTS system are

depleted.

Replace the batteries in the MTS

system.

Programmer battery is drained. Charge the programmer battery .

MTS communication cable is

disconnected.

Connect the MTS communication

cable to the programmer and the

MTS system.

CF card cable is disconnected

or improperly seated in the

programmer

Connect the CF card cable to the

MTS communication cable, and

properly seat the CF card cable in

the programmer.

NOTE: When removing the CF

card cable, wait about 3 seconds

before reinserting it into the

programmer.

MTS communication cable is

damaged or malfunctioning.

Replace the MTS communication

cable.

CF card cable is damaged or

malfunctioning.

Replace the CF card cable.

MTS system is damaged or

malfunctioning.

Replace the MTS system.


malfunctioning.




Patient is

not receiving

stimulation.

Programmer is in demo mode Exit the programming session and





Stimulation is off. Turn on stimulation.

IPG battery is low and stimulation

shut off (rechargeable IPGs).

Recharge the IPG.

Lead is damaged or has become

disconnected.

Check impedance on the

lead using the programmer. If

impedance is high, then the lead

may be damaged or disconnected.

Check the connections or consider

replacing the lead.

Refer to “Measuring Impedance”

for more information.

IPG battery is depleted

(nonrechargeable) or unable to

hold a charge (rechargeable).

Replace the IPG. Contact

Technical Support.

IPG is damaged or malfunctioning. Replace the IPG. Contact

Technical Support.

Parameter boxes

on the Testing

screen turn

yellow.

Generator has reached its output

limit

Reduce the amplitude or pulse

width.

-OR-

Set additional polarities (anode or

cathode) on the lead.

Lead is damaged or has become

disconnected.

Check impedance on the

lead using the programmer. If

impedance remains high despite

changes to program settings,

then the lead may be damaged

or disconnected. Check the

connections or consider replacing

the lead.

Refer to “Measuring Impedance”

for more information.



Patient record

will not export to

database card .

Database card is not seated

properly in the card slot on the

programmer.

Remove and reseat the database

card to ensure it is inserted

properly.

Database card is full. Use another database card .

Database card is locked from

editing.

Exit the patient database and

return to the Main Menu screen,

remove the database card and

slide the lock on the side of the

card to a down (unlocked) position,

and reinsert the database card .

Database card is damaged or

corrupt.

Replace the database card .

Database is not

restored from the

database card .

Database card is not seated

properly in the card slot on the

programmer.

Remove and reseat the database

card to ensure it is inserted

properly.

Programmer will not read the data

stored on the database card .

Try to view fi les on the database

card using another programmer.

If the fi les are viewable,

then the programmer may be

malfunctioning. Contact Technical

Support.

Database card is locked from

editing.

Exit the patient database and

return to the Main Menu screen,

remove the database card and

slide the lock on the side of the

card to a down (unlocked) position,

and reinsert the database card .

Database card is damaged or

corrupt.

Replace the database card . (You

will not be able to restore your

database.)


Performing a Soft Reset

If the programmer is locked and will not respond to input, you can use

the soft reset feature to restart the system. This is similar to rebooting

your computer. When you soft reset the system, stored patient records and

confi gured settings are unaffected. Note that even if the programmer is

locked, you can still turn off stimulation to the patient using the power key

on the patient programmer or MTS™ system.

CAUTION: When performing a soft reset , you will lose any unsaved

data.

If the Device Is Locked

Using the stylus, press the small recessed button located on the right

side of the programmer. The system will reset and return to the Main

Menu screen.

Figure 59: Using the stylus to perform a soft reset

If the System Responds to Input

1. On the Main Menu screen, tap the Tools menu, and then tap Reset

PDA. The Confirm Reset message appears.

2. Tap OK. The programmer resets.


Reinstalling the Software

If you are having problems operating your system after performing a soft

reset , you may try reinstalling the software to reinitialize the system. When

you reinstall the software, stored patient records and confi gured settings

except system volume are unaffected.

To reinstall the software, follow these steps:

1. On the Main Menu screen, tap Tools, then tap Reinstall Software. The

Confirm Reinstall message appears.

Figure 60: The Confi rm Reinstall message

2. Tap OK. The “Installing Rapid Programmer™ 3.7” screen appears and

the PDA reinstalls the programmer software.

3. When the Installation Complete screen appears, tap Finish. The

programmer restarts.

Copying Log Files

If an error occurs and you are unable to operate the programmer, you can

copy the log fi les to a database card and then send the card to St. Jude

Medical for inspection or call Technical Support for further instructions.

To copy log fi les to a database card , follow these steps:

1. Insert a database card in the card slot on top of the programmer.


2. On the Main Menu screen, tap the Tools menu, and then tap Copy Log

Files.

3. When the Copy Complete message appears, tap OK.

Returning the Rapid Programmer System for Service

If you must return the Rapid Programmer™ system for service, keep your

database card and erase the database from the programmer before you

return it. To do this, follow these steps:

1. Remove the database card containing the patient data, and store the

database card in a safe place to maintain data integrity (see Appendix

B for storage conditions).

2. From the Main Menu screen, tap Settings, then Brightness. The

Brightness Level screen appears.

3. If the on-screen keyboard is not visible, tap to open it.

4. Type clear and then tap the ENTER key ( ).

5. In the Clear All Patient Data message that appears, tap OK. All backup

databases are deleted from the Rapid Programmer system.

Figure 61: The Clear All Patient Data message

6. When the message appears confirming that the patient data has been

deleted, tap OK.

7. Return the programmer to St. Jude Medical (see “Technical Support”).


Service and Ordering Information

This section provides information for contacting Technical Support and for

ordering parts and accessories.

Technical Support

For technical questions and support for you St. Jude Medical™

neuromodulation product, use the following information:

+1 972 309 8000

+1 800 727 7846 (toll-free within North America)

For additional assistance, call your local St. Jude Medical representative.


Ordering Information

The following table lists model numbers for ordering the kit, kit

components, and accessories for the Rapid Programmer™ system.

Table 8: Accessories and kit components for the Rapid Programmer system

Model Number Description

1273 MTS communication cable

1280 IrDA communication cable

1291 Compact fl ash to DB9 cable

1300 Printer paper

1303 Battery for Bluetooth printer

1304 Car charger, RP Model 3834

1321 Power adapter for Bluetooth printer

1601 Rapid Programmer case

1622 Power adapter for RP Model 3834

1626 Stylus for RP Model 3834

1627 MTS joining sleeve for RP Model 3834

1629 Extended battery for RP Model 3834

3805 Rapid Programmer database card

3823 Bluetooth printer

3834 Rapid Programmer


Appendix A: Printable Reports of the Rapid Programmer System

This section provides examples of the types of reports that you can print

from the Rapid Programmer™ system and provides information about what

information is available on each report. For more information on printing

reports , see the “Printing” section. The Rapid Programmer system can print

the following types of reports :

Neurostimulation record

Patient list

Lead diagnostics report

Neurostimulation Record

A neurostimulation record contains a record of all programs, as well as lead

and generator information, for a selected patient. The following fi gure shows

the location of information on the report.

1

3

4

5

7

6

2

Figure 62: Parts of a neurostimulation

record

Legend:

1. Patient information.

2. Generator and lead information,

including the initial session date and

the serial number of the generator.

3. Information about the device the

patient uses to control stimulation,

including the serial number of the

device and the number of hours that

stimulation has been on.

4. Date of the programming session.

5. Program number for the stim set

settings that follow.

6. Stimulation map of the associated

program.

7. Stim set settings of the associated

program. Stim set are listed in

ascending order (1, 2, 3, etc.).


Patient List

The patient list shows patient names from the database and provides the

dates of their last revisions. The following fi gure shows the location of

information on the report.

1 2

Figure 63: Parts of a patient list

Legend:

1. Patient name.

2. Date of the patient’s last programming

session.

Lead Diagnostics Report

A lead diagnostics report shows the results of the diagnostic testing

(impedance testing) performed on a generator and leads for a program on an

Eon™, Prodigy™, Protégé™, or MTS™ system. The following fi gure shows

the location of information on the report.

1

3 4

2

Figure 64: Parts of a lead

diagnostics report

Legend:

1. Patient name and information about

the system being calibrated, including

stimulator and lead information.

2. Session date of the diagnostic test.

3. Number of the electrode that was

tested.

4. Impedance reading of the associated

electrode.


Appendix B: Specifications

The following tables show hardware specifi cations for the Rapid

Programmer™ system (Model 3834).

Table 9: Rapid Programmer system specifi cations

System Specifications

OEM Model HP iPAQ 200 series

Memory 128 MB SDRAM

256 MB fl ash ROM

Display 4.0-in. VGA TFT, resolution 640 × 480 px

Communications Bluetooth® wireless technology 2.0, 10 meter range (approximately

33 feet), high-speed, low-power, short-range wireless

communication with other Bluetooth devices, support collaborative

coexistence with IEEE 802.11b/g

Indicator Lights Solid amber: battery charging

Solid green: battery charge complete

Solid blue: Bluetooth wireless technology is on

Battery 3800 mAh, lithium ion, removable, rechargeable battery

Table 10: Rapid Programmer system physical specifi cations

Physical Specifications

Metric U.S.

Height 13.38 cm 5.27 in

Width 7.54 cm 2.97 in

Depth 2.41 cm 0.95 in

Weight 238.00 g 8.40 oz

Table 11: Rapid Programmer system storage and operating conditions

Storage and Operating Conditions

Metric U.S.

Temperature Range Operating 10°C–40°C 50°F–104°F

Storage -10°C–55°C 14°F–131°F

Humidity Range (Noncondensing) Operating 30%–75% 30%–75%

Storage 30%–90% 30%–90%

Pressure Range Operating 70–101 kPa 10.2–14.6 psi

Storage 70–101 kPa 10.2–14.6 psi


Appendix C: Regulatory Statements

This section contains regulatory statements about the system or its

accessories.

Statement of FCC Compliance

This equipment has been tested and found to comply with the limits

for a Class B digital device, pursuant to part 15 of the FCC rules. These

limits are designed to provide reasonable protection against harmful

interference in a residential installation. This equipment generates, uses,

and can radiate radiofrequency energy and, if not installed and used in

accordance with the instructions, may cause harmful interference to radio

communications. However, there is no guarantee that interference will not

occur in a particular installation. If this equipment does cause harmful

interference to radio or television reception, which can be determined by

turning the equipment off and on, the user is encouraged to try to correct

the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.

Consult the dealer or an experienced radio/TV technician for help.

Operation is subject to the following two conditions:

This device may not cause harmful interference.

This device must accept any interference received, including

interference that may cause undesired operation.

Modifi cations not expressly approved by the manufacturer could void the

user’s authority to operate the equipment under FCC rules.

Declaration of Conformity (Industry Canada) Notice to Users of Radio and Television

This Class B digital apparatus meets all the requirements of the Canadian

interference-causing equipment regulations.


Disposal Guidelines for Battery-Powered Devices

This device contains a battery and the label is affi xed to this device in

accordance with European Council directives 2002/96/EC and 2006/66/

EC. These directives call for separate collection and disposal of electrical

and electronic equipment and batteries. Sorting such waste and removing

it from other forms of waste lessens the contribution of potentially toxic

substances into municipal disposal systems and into the larger ecosystem.

Return the device to St. Jude Medical at the end of its operating life.


Appendix D: Symbols and Definitions

The following symbols may be used in this document and on some of the

products and packaging.

Table 12: Symbols and defi nitions

Symbol Description

Caution, consult accompanying documents

Consult instructions for use

Follow instructions for use on this website

Magnetic Resonance (MR) Unsafe, an item poses unacceptable

risks to the patient, medical staff, or other persons within an

MR environment

Expiration date

Date of manufacture

Manufacuring facility

Temperature limits for storage conditions

Humidity limits

Pressure limits

Catalog number

Manufacturer

Contents quantity

Programmer

Accessories

SN Serial number


Symbol Description

Batch code

Prescription use only

This product shall not be treated as household waste. Instead

it is the user’s responsibility to return this product to St. Jude

Medical for reprocessing.

By ensuring that this product is disposed of properly, you

will help prevent potential negative consequences for the

environment and human health, which could be caused by

inappropriate waste handling of this product. The recycling of

materials will help to conserve natural resources.

For more information about how to return this product for recycling,

please contact St. Jude Medical.

Complies with AS/NZS standards: AS/NZS 4268:2003

This device is listed by Underwriters Laboratories (UL) Inc. as

certifi ed

This equipment has been tested and found to comply with the

limits for a Class B digital device, pursuant to Part 15 of the

FCC rules.


Appendix E: Electromagnetic Compatibility Guidelines

The Rapid Programmer™ system (Model 3834), hereafter the system, is

part of a medical equipment system and should be used with the following

guidance:

Table 13: Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The system is intended for use in the electromagnetic environment specifi ed below. The

customer or user of the system should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions

CISPR 11

Group 1 The system uses RF energy only for its internal

function.

Therefore, its RF emissions are very low and are

not likely to cause any interference in nearby

electronic equipment.

RF emissions

CISPR 11

Class A The system is suitable for use in all

establishments other than domestic and those

directly connected to the public low-voltage

power supply network that supplies buildings

used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fl uctuations/

fl icker emissions

IEC 61000-3-3

Not applicable


Index

A

Active Balancing, 52, 55

Amplitude

Comfort, 38, 40, 52

Maximum tolerable, 55

Overriding usage range for, 55, 56

Perception, 27, 28, 38, 40, 41,

42, 43, 51, 52, 53, 55

Target, 41

B

Battery, 1, 2, 3, 9, 10, 17, 19, 20,

21, 22, 23, 40, 73, 74, 75, 76,

77, 84, 87

Charging, 10

Disposal, 89

Status, 22

Bolus mode, 50, 51

Burst program

Adding a burst pulse, 38, 41

Defi nition, 37

Deleting a burst pulse, 36, 38

Setting frequency, 39

Switching to, 29, 35, 37

C

Calibrating

Touch screen, 24

Card, 8, 15, 16, 57, 65, 66, 67,

79, 81, 82, 84

Inserting, 15

Removing, 16

Connecting to devices, 12, 13

Continuous mode, 50, 51

Cycle mode, 50, 51

D

Database

Accessing, 58

Adding a patient, 61

Backup, 67

Buttons and icons, 57

Combining patient records, 64

Deleting, 82

Deleting a patient, 63

Editing a patient, 62

Exporting, 66, 79

Merging and copying, 65

Password, 58, 60

Restore, 18

Restoring, 67, 79

Demo, 18, 26, 27, 76, 77, 78

Dynamic MultiStim programming,

45, 46, 55

E

Electrodes, 42

Polarity, 38, 42

F

Frequency, 31, 38, 39, 45

I

Impedance testing, 29, 31, 48, 49,

68, 78

IPG

As anode, 38, 39

Modes, 50

L

Lead, 78

Diagnostics. See Impedance

testing

Lead diagnostics report, 49, 71

Leads

Selecting, 26, 30, 34


M

Magnet mode, 29, 50

Maximum output. See Output limit

MultiSteering programming, 28, 31,

42, 43

MultiStim. See Dynamic MultiStim

O

Ordering information, 84

Output limit, 40

P

Printing, 68, 69, 70

Lead diagnostics report, 49

Neurostimulation record, 61

Patient list, 59

Program

Editing, 36

Saving, 52

Programming, 1, 2, 26, 27, 28, 31,

32, 34, 40, 41, 42, 43, 45, 46,

47, 51, 52, 54, 55, 74, 76, 77,

78

Burst, 29, 37, 39, 41

Tonic, 37, 39, 40, 42, 45, 47,

52, 55

Program mode, 50, 51

Programs

Adding, 35

Copying, 35

Deleting, 36

Downloading, 54, 55

Pulse width, 31, 39

R

Reports, 85

Lead diagnostics report, 68, 86

Neurostimulation record, 61, 68,

69, 85

Patient list, 57, 59, 68, 70

Types of, 68, 85

Resetting the MTS usage counter,

34

S

SD card. See Database card

Settings

Automatic shutoff, 23

Backlight, 19

Brightness, 20

Time and date, 21

Volume, 25

Soft reset, 75, 80, 81

Step size, 40

Stim sets

Adding, 41, 45, 48

Deleting, 36

Replacing, 47, 48

Selecting, 45

Stimulation map, 38, 43, 44

Symbols, 90

T

Technical support, 83

Test log, 26, 47

Tonic program

Defi nition, 37

Switching to, 37

Troubleshooting, 74

*100144565* 2016-09ARTEN100144565 A

St. Jude Medical

6901 Preston Road

Plano, Texas 75024

USA

+1 972 309 8000

St. Jude Medical

Coordination Center BVBA

The Corporate Village

Da VinciIaan 11 Box F1

1935 Zaventem

Belgium

+32 2 774 68 11

sjm.com

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